Itrafungol Capsule (Itraconazole)

Adult dose

To increase absorption, this medicine should preferably be administered immediately after a meal. The capsule must be swallowed whole. 1. Short-term treatment This medicine continues to exert a therapeutic effect in skin tissue even after treatment is discontinued. Therefore, the final clinical and mycological response should preferably be assessed 2～4 weeks after completing the prescribed course of treatment. 1) Vulvovaginal candidiasis: Administer itraconazole 200 mg per dose twice daily (morning and evening) for 1 day, or 200 mg once daily for 3 days. 2) Pityriasis versicolor: Administer 200 mg once daily for 7 days. 3) Tinea corporis, tinea cruris: Administer 100 mg once daily for 15 days. 4) Tinea manuum (interdigital), tinea pedis (interdigital): Administer 100 mg once daily for 15 days. 5) Tinea manuum (palms), tinea pedis (soles): Administer 100 mg once daily for 30 days or 200 mg per dose twice daily for 7 days. 6) Oral candidiasis: Administer 100 mg once daily for 15 days. 7) Fungal keratitis: Administer 200 mg once daily for 21 days. 2. Onychomycosis 1) Pulse therapy Administer 200 mg per dose twice daily for 1 week, followed by a 3-week drug-free period; this constitutes 1 cycle. Administer up to 2 cycles for infection of the fingernails only and up to 3 cycles for infection of the toenails. Site of onychomycosis Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Toenails (with or without concomitant fingernail infection) Treatment Drug-free Treatment Drug-free Treatment Fingernails Treatment Drug-free Treatment 2) Continuous therapy Administer 200 mg once daily for 3 months. The therapeutic effect continues for 3 months for fingernails and 6 months for toenails after the end of treatment. 3. Systemic fungal infections In patients with impaired immune function, such as those with neutropenia, AIDS, or organ transplants, the oral bioavailability of this medicine may be reduced; if necessary, double the dose. Indication / Dose / Average treatment duration1 / Notes Aspergillosis / 200mg once daily / 2~5 months / For invasive or disseminated disease, increase to 200mg per dose twice daily Candidiasis / 100~200mg once daily / 3 weeks~7 months Cryptococcal meningitis / 200mg twice daily / 2 months~1 year Maintenance therapy (for AIDS patients only): 200mg once daily2 Paracoccidioidomycosis / 100mg once daily / 6 months / No efficacy data are available for this dosage regimen for the treatment of paracoccidioidomycosis in AIDS patients. 1 Treatment duration should be adjusted according to clinical response. 2 Treatment duration should depend on immune recovery.

This drug should be used with caution in patients with impaired cardiac function, especially in those with congestive heart failure, as it may pose life-threatening risks. Patients with allergies to this drug or its components should refrain from taking it, and individuals with certain heart diseases, liver dysfunction, or renal impairment must consult with their doctor before use. Since this drug is primarily metabolized in the liver, regular liver function tests should be conducted in patients with hepatic impairment, and liver damage should be monitored. Additionally, this drug has many potential drug interactions, and serious side effects may occur if taken with certain medications; therefore, it's important to inform the prescriber of any other medications currently being taken. Pregnant or potentially pregnant women, as well as nursing mothers, should not take this medication and effective contraception should be used afterward. Special caution is required for children and the elderly, and it should only be administered if the benefits are deemed to outweigh the risks. In cases of overdose, there is no specific antidote, so symptomatic treatment should be implemented; this drug is not removed by hemodialysis. When storing, keep it out of reach of children and store it in its original container to prevent misuse or quality degradation.

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory infection, leukopenia, hypersensitivity, dysgeusia, sensory loss, sensory disturbances, tinnitus, constipation, diarrhea, indigestion, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylactoid reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, altered mental status, peripheral neuropathy, dizziness, drowsiness, tremors, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, voice disorders, cough, gastrointestinal disorders, liver failure, hepatitis, jaundice, erythematous rash, hyperhidrosis, myalgia, arthralgia, renal impairment, urinary incontinence, generalized edema, facial edema, chest pain, fever, pain, fatigue, chills, leukocytosis, eosinophilia, anemia, vasculitis, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual impairment, hearing loss, ventricular ectopic beats, atrioventricular block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal and lumbar pain, pancreatitis, elevated serum total protein, elevated total bilirubin, increased LAP, decreased appetite, malaise, brown urine, increased liver enzyme levels, mucosal skin syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riel syndrome, erythema multiforme, hair loss, photosensitivity, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, elevated BUN, positive urine protein reaction, positive urine glucose reaction, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, elevated serum triglyceride levels, warmth, elevated serum uric acid levels, elevated serum potassium levels, congestive heart failure, dyspnea

This drug should be stored in a tightly closed container to prevent air ingress, keeping the storage temperature between 1 to 30 degrees Celsius at room temperature. Storing it this way helps maintain its effectiveness and prevents deterioration.

Appearance

A hard capsule with upper blue and lower pink containing spherical pellets that are white or grayish-white.

Package unit

28 capsules/bottle, 200 capsules/bottle